R350™ guidewire

GUDID M20673900

The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.

Vascular Solutions, Inc.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: M20673900
• NIH Device Record Key: 9e4dbc4f-62f6-4767-8148-078cc6d44bb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R350™ guidewire
• Version Model Number: 7390
• Company DUNS: 008999906
• Company Name: Vascular Solutions, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-240-6001
• Email: customerservice@vasc.com

Device Dimensions

• Length: 350 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M20673900 [Primary]
HIBCC	M20673901 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• DQX: Wire, Guide, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-11
• Device Publish Date: 2016-09-05

Devices Manufactured by Vascular Solutions, Inc.

• M20677101 - Vascular Solutions Custom Access Kit: 2023-06-09
• M20677141 - Vascular Solutions Custom Access Kit: 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
• M20677181 - Vascular Solutions Custom Access Kit: 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
• M20677191 - Vascular Solutions Custom Access Kit: 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
• M20677201 - Vascular Solutions Custom Access Kit: 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
• M20677211 - Vascular Solutions Custom Access Kit: 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
• M20677221 - Vascular Solutions Custom Access Kit: 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following
• M20677231 - Vascular Solutions Custom Access Kit: 2023-06-09 The Custom Access Kit is intended to introduce up to a 0.038”/0.89mm guidewire or catheter into the vascular system following